Trials / Unknown
UnknownNCT03604029
Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities
Evaluating the Diagnostic Performance of Near Infrared Spectroscopy (NIRS) in the Setting of Acute Compartment Syndrome (ACS) in Traumatized Lower Extremities
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Nonin Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.
Detailed description
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). We have shown NIRS can be helpful in diagnosing ACS. We think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. We have studied the capabilities of NIRS for many years. The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines. The goal of this study is to test and prove our clinical guidelines we developed through previous work. This is an interventional study, which means the data we collect will be used to manage the patient and their care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Near Infrared Spectroscopy | Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation. |
Timeline
- Start date
- 2019-01-07
- Primary completion
- 2021-06-30
- Completion
- 2022-02-28
- First posted
- 2018-07-27
- Last updated
- 2020-09-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03604029. Inclusion in this directory is not an endorsement.